POS0731 ASSOCIATION OF PATIENT-REPORTED OUTCOMES WITH TYPE I INTERFERON GENE SIGNATURE FROM THE INTERNATIONAL SYSTEMIC LUPUS ERYTHEMATOSUS PROSPECTIVE OBSERVATIONAL COHORT STUDY (SPOCS)
Authors: M. Aringer, L. Arnaud, C. Peschken, R. Furie, E. F. Morand, C. Seo, E. Rapsomaniki, J. Hedberg, J. Knagenhjelm, T. Grünfeld Eén, B. Desta, R. Tummala, A. Sorrentino, H. Stirnadel-Farrant
Journal: Annals of the Rheumatic Diseases (2022)

Background The aim of the Systemic Lupus Erythematosus Prospective Observational Cohort Study (SPOCS) is to examine the disease course of patients with systemic lupus erythematosus (SLE) in relation to their type I interferon gene signature (IFNGS) status. 1 IFNGS has been associated with SLE disease activity. 2 Objectives To identify associations between IFNGS status and patient-reported outcomes (PROs) among patients receiving clinical care while enrolled in SPOCS. Methods This noninterventional, international, prospective, observational cohort study included adult patients (≥18 years) with moderate to severe SLE receiving standard therapy. Short Form 36 Health Survey version 2 (SF-36; 0–100), Lupus Quality of Life (LupusQoL; 0–100) and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F; 0–52) were assessed at baseline, 6 months, and 12 months. Higher scores indicate better outcomes. Analyses were stratified by high or low IFNGS status (4-gene test) at baseline. Results Of 827 patients, mean (standard deviation [SD]) age was 45.1 (14.0) years, 771 (93%) were female, 525 (63%) were IFNGS high, and 219 (26%) were IFNGS low. IFNGS-high patients were younger than IFNGS-low (mean [SD] 43.0 [13.7] vs 50.7 [12.9] years), had fewer comorbidities (83% vs 91%) and similar baseline disease activity (mean [SD]: SLE Disease Activity Index 2000, 9.8 [4.3] vs 9.2 [5.2]; Physician’s Global Assessment, both 1.5 [0.6]). At baseline, there were some differences in PROs between IFNGS-high and -low patients. At Month 12, changes in most domains did not meet the minimal clinically important difference (MCID). Slight improvement was observed only in selected domains in the IFNGS-high group. This group was younger and had fewer comorbidities at baseline. (Table 1, Figure 1). Table 1. PRO Scores at Baseline and Month 12 by IFNGS Status Baseline Month 12 Change From Baseline MCID (≥) PRO Total (n=810) IFNGS High IFNGS Low (n=219) Total (n=431) IFNGS High IFNGS Low (n=147) Total IFNGS High IFNGS Low (n=525) (n=279) SF-36 Physical Component Summary 37.4 (10.5) 38.3 (10.5)+ 35.2 (10.6)1 39.8 (10.8) 41.7 (10.4)+ 35.7 (10.8) 2.3 (7.6) 3.0 (8.1)* 0.6 (6.4) 2.5 Mental Component Summary 43.2 (11.6) 43.6 (11.7) 42.7 (11.6) 44.9 (11.2) 45.9 (10.6) 43.4 (11.5) 0.9 (9.2) 1.4 (9.6) -0.3 (8.4) 2.5 LupusQoL Physical health 56.4 (27.4) 58.1 (27.0)+ 52.1 (27.7) 60.5 (26.9) 65.0 (25.3)+ 52.5 (27.7) 2.6 (18.1) 5.0 (19.2)* -1.4 (16.4) 3.4 Pain 54.3 (30.3) 55.7 (29.8) 50.2 (30.8) 61.4 (28.5) 66.0 (26.5)+ 52.6 (29.1) 5.4 (23.8) 8.1 (25.2) 0.7 (21.3) 8.5 Planning 61.4 (32.2) 63.7 (31.8)+ 57.0 (32.2) 66.3 (29.6) 70.8 (27.8)+ 58.5 (30.8) 2.9 (24.4) 4.2 (24.7) -1.0 (22.9) 6.5 Intimate relationships 58.0 (34.8) 61.2 (34.1)+ 50.9 (34.8) 59.8 (33.9) 65.6 (32.3)+ 50.6 (34.7) -0.6 (24.5) -0.7 (25.9) -0.8 (22.3) 9.2 Burden to others 50.7 (32.6) 50.7 (32.6) 50.4 (33.5) 56.4 (30.7) 59.7 (29.5) 51.8 (31.7) 3.1 (25.4) 5.6 (26.0)* 0.1 (23.9) 5.3 Emotional health 66.3 (25.6) 66.1 (26.0) 67.8 (24.8) 71.1 (24.7) 72.9 (23.8) 69.2 (24.7) 1.8 (19.4) 3.1 (20.3) -0.5 (18.1) 3.4 Body image 62.6 (29.4) 61.0 (30.1) 66.4 (28.3) 68.2 (27.6) 70.3 (27.4) 65.1 (27.0) 2.0 (23.9)* 4.1 (24.3)* -0.4 (22.1) 1.1 Fatigue 48.6 (27.8) 49.9 (27.6) 45.5 (28.2) 53.7 (26.9) 57.4 (26.2)+ 46.9 (25.7) 2.1 (19.3) 3.5 (20.0) -0.9 (18.7) 3.9 FACIT-F 25.8 (13.4) 26.9 (13.4)+ 23.4 (12.9) 28.7 (13.2) 31.1 (12.7)+ 24.6 (12.9) 2.3 (9.6) 3.2 (10.2) 0.6 (8.5) 4.0 Data are mean (SD). Asterisks (*) indicate changes from baseline ≥ MCID. +Comparison between high and low IFNGS status by Mann-Whitney U test (nominal p-value&lt;0.01). Data for n are patients per subgroup and do not reflect responses per PRO assessment. Conclusion In this cohort study, patients with moderate to severe SLE had poor health status, health-related quality of life, and fatigue. A clinically meaningful change was not met in most PROs, suggesting patients continue to have a high need for improved treatment options. References [1]Hammond ER. BMJ Open 2020;10:e036563. [2]Dall’era MC. Ann Rheum Dis 2005;64:1692–7. Acknowledgements Writing assistance by Shelley Harris, PhD (Fishawack). This study was sponsored by AstraZeneca. Disclosure of Interests Martin Aringer Speakers bureau: AbbVie, AstraZeneca, BMS, Boehringer Ingelheim, Chugai, HEXAL, Lilly, MSD, Mylan, Novartis, Roche, Sanofi, UCB, Consultant of: AbbVie, AstraZeneca, BMS, Boehringer Ingelheim, Galapagos, GSK, Pfizer, Roche, Sanofi, Laurent Arnaud Speakers bureau: AstraZeneca, Consultant of: AstraZeneca, Grant/research support from: AstraZeneca, Christine Peschken Consultant of: AstraZeneca, GSK, Grant/research support from: AstraZeneca, Richard Furie Speakers bureau: AstraZeneca, Genentech, Consultant of: AstraZeneca, Grant/research support from: AstraZeneca, Eric F. Morand Speakers bureau: GSK, Novartis, Paid instructor for: AstraZeneca, Biogen, Eli Lilly, Consultant of: AstraZeneca, Biogen, Bristol Myers Squibb, Eli Lilly, EMD Serono, Genentech, GSK, Janssen, Servier, Grant/research support from: Abbvie, AstraZeneca, Bristol Myers Squibb, GSK, Janssen, Caroline Seo Shareholder of: AstraZeneca, Employee of: AstraZeneca, Eleni Rapsomaniki Employee of: AstraZeneca, Jonatan Hedberg Shareholder of: AstraZeneca, Employee of: AstraZeneca, Jacob Knagenhjelm Shareholder of: AstraZeneca, Employee of: AstraZeneca, Tina Grünfeld Eén Shareholder of: AstraZeneca, Employee of: AstraZeneca, Barnabas Desta Shareholder of: AstraZeneca, Employee of: AstraZeneca, Raj Tummala Shareholder of: AstraZeneca, Employee of: AstraZeneca, Alessandro Sorrentino Shareholder of: Galapagov, Abbott Laboratories, Gilead Sciences, Moderna, Employee of: Janssen, Sanofi, AstraZeneca, Heide Stirnadel-Farrant Shareholder of: AstraZeneca, GSK, Employee of: AstraZeneca